Back to resultsA Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping
Primary Purpose
Rhabdomyosarcoma, Melanoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tc99m tilmanocept
Vital Blue Dye (optional)
Lymph Node Mapping
Sponsored by
About this trial
This is an interventional diagnostic trial for Rhabdomyosarcoma
Eligibility Criteria
Inclusion Criteria:
- The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
- Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate
- The subject is clinically node negative (cN0) at the time of screening
- Age < 18 years
- Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
- Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study
Exclusion Criteria:
- The subject has had preoperative radiation therapy
- Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure
- Has a known allergy to dextran or VBD (if intended to be used)
- Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator
- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
Sites / Locations
- Nemours Children's Specialty Care
- Nemours Children's Hopsital
- Children's Hospital Medical Center
- Nationwide Children's Hospital
- Children's Hospital of Pittsburgh
- The University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tc99m tilmanocept and Vital Blue Dye (optional)
Arm Description
0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).
Outcomes
Primary Outcome Measures
Incidence of adverse events in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping
Evaluation of safety and tolerability of Lymphoseek
Secondary Outcome Measures
Changes in vital signs
Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each vital sign parameter by time point, for each tumor type and overall.
Changes in laboratory parameters
Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each quantitative laboratory parameter by time point, for each tumor type and overall.
Changes in ECG parameters
Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each ECG parameter by time point, for each tumor type and overall.
Number of lymph nodes identified preoperatively using SPECT or SPECT/CT
Proportion of subjects who underwent preoperative SPECT or SPECT/CT and proportion of subjects with a lymph node identified preoperatively using SPECT or SPECT/CT
Agreement of the number of nodes identified by preoperative SPECT or SPECT/CT to intraoperative localization
Subject and nodal agreement of central pathology assessment with local pathology assessment of the excised lymph node(s) to confirm the presence/absence of tumor metastases
Number of changes in postsurgical treatment plan in relation to nodes identified by Lymphoseek
Changes to postsurgical treatment plan will be compared to baseline treatment plan.
Number of lymph nodes identified intraoperatively per subject
Nodal false negative rate for nodes identified
The number of pathology-positive lymph nodes that were missed intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent.
Nodal sensitivity
The number of pathology-positive lymph nodes that were identified intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent.
Upstaging
The proportion of patients with pathology-positive lymph nodes who had at least one pathology-positive lymph node that was identified by Lymphoseek and had no other pathology-positive lymph nodes (i.e., identified by any other method)
Change in subject nodal staging before and after surgery based upon nodes identified
Subject localization rates
The proportion of subjects with Lymphoseek-identified lymph nodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02509598
Brief Title
A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping
Official Title
A Prospective, Open-Label, Multicenter Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
March 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardinal Health 414, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhabdomyosarcoma, Melanoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tc99m tilmanocept and Vital Blue Dye (optional)
Arm Type
Experimental
Arm Description
0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).
Intervention Type
Drug
Intervention Name(s)
Tc99m tilmanocept
Other Intervention Name(s)
Lymphoseek
Intervention Description
A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery
Intervention Type
Drug
Intervention Name(s)
Vital Blue Dye (optional)
Other Intervention Name(s)
Lymphazurin, Isosulfan Blue
Intervention Description
A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care).
Intervention Type
Procedure
Intervention Name(s)
Lymph Node Mapping
Intervention Description
Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection
Primary Outcome Measure Information:
Title
Incidence of adverse events in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping
Description
Evaluation of safety and tolerability of Lymphoseek
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Changes in vital signs
Description
Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each vital sign parameter by time point, for each tumor type and overall.
Time Frame
14 Days
Title
Changes in laboratory parameters
Description
Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each quantitative laboratory parameter by time point, for each tumor type and overall.
Time Frame
14 Days
Title
Changes in ECG parameters
Description
Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each ECG parameter by time point, for each tumor type and overall.
Time Frame
14 Days
Title
Number of lymph nodes identified preoperatively using SPECT or SPECT/CT
Time Frame
1 Day
Title
Proportion of subjects who underwent preoperative SPECT or SPECT/CT and proportion of subjects with a lymph node identified preoperatively using SPECT or SPECT/CT
Time Frame
1 Day
Title
Agreement of the number of nodes identified by preoperative SPECT or SPECT/CT to intraoperative localization
Time Frame
1 Day
Title
Subject and nodal agreement of central pathology assessment with local pathology assessment of the excised lymph node(s) to confirm the presence/absence of tumor metastases
Time Frame
1 Day
Title
Number of changes in postsurgical treatment plan in relation to nodes identified by Lymphoseek
Description
Changes to postsurgical treatment plan will be compared to baseline treatment plan.
Time Frame
1 Day
Title
Number of lymph nodes identified intraoperatively per subject
Time Frame
1 Day
Title
Nodal false negative rate for nodes identified
Description
The number of pathology-positive lymph nodes that were missed intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent.
Time Frame
1 Day
Title
Nodal sensitivity
Description
The number of pathology-positive lymph nodes that were identified intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent.
Time Frame
1 Day
Title
Upstaging
Description
The proportion of patients with pathology-positive lymph nodes who had at least one pathology-positive lymph node that was identified by Lymphoseek and had no other pathology-positive lymph nodes (i.e., identified by any other method)
Time Frame
1 Day
Title
Change in subject nodal staging before and after surgery based upon nodes identified
Time Frame
1 Day
Title
Subject localization rates
Description
The proportion of subjects with Lymphoseek-identified lymph nodes
Time Frame
1 Day
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate
The subject is clinically node negative (cN0) at the time of screening
Age < 18 years
Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study
Exclusion Criteria:
The subject has had preoperative radiation therapy
Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure
Has a known allergy to dextran or VBD (if intended to be used)
Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator
Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Blue, MD
Organizational Affiliation
Cardinal Health 414, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Nemours Children's Specialty Care
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Nemours Children's Hopsital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping
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